D.C. Week: Trump Announces Plan to Tackle High Drug Costs

Also: Key White House official in charge of pandemic response leaves

WASHINGTON -- President Trump announced his long-awaited proposal for tackling high drug costs in a speech at the Rose Garden Friday afternoon. Also this week, the administration rejected one state's proposal to set a lifetime limit on Medicaid participation, and a national-security reshuffle left the government without anyone to lead its response to the next infectious disease pandemic.

"Everyone is involved in this broken system -- the drugmakers, insurance companies, distributors, and pharmacy benefit managers (PBMs) and many others contribute to the problem," Trump said during an address in the sun-filled White House Rose Garden.

"The government is also partly responsible," Trump added. "Previous leaders have turned a blind eye to this incredible abuse, but under this administration, we're putting American patients first." In fact, "American Patients First" is the formal name for the administration's plan, which can be seen on the Department of Health and Human Services (HHS) website.

He also singled out Big Pharma for special criticism, noting that drug companies spent $280 million on lobbying last year, "more than tobacco, oil, and defense contractors combined."

"We have determined that we will not approve Kansas' recent request to place a lifetime limit on Medicaid benefits for some beneficiaries," CMS administrator Seema Verma said in prepared remarks at the annual meeting of the American Hospital Association (AHA) . "We seek to create a pathway out of poverty, but we also understand that people's circumstances change, and we must ensure that our programs are sustainable and available to them when they need and qualify for them."

But CMS did try to offer the state other ways to meet its Medicaid goals. "We have approved, in other states, meaningful incentives for certain adults to participate in community engagement activities and to take greater responsibility for their health and well-being, including periods of ineligibility for failing to comply with these requirements," Verma said in a letter sent Monday to Jon Hamdorf, the state's acting Medicaid director.

Head of Pandemic Response Leaves White House

The White House official in charge of responding to a lethal pandemic has exited the Trump administration and his global health security team dissolved, due to a "reorganization" by national security adviser John Bolton, The Washington Post reported on Thursday.

"The abrupt departure of Rear Adm. Timothy Ziemer from the National Security Council means no senior administration official is now focused solely on global health security," wrote Lena Sun for The Post.

Ziemer's last day was Tuesday. What else happened Tuesday? A new Ebola outbreak was confirmed in central Africa.

NSC spokesman Robert Palladino told The Post on Wednesday the administration "remains committed to global health, global health security and biodefense, and will continue to address these issues with the same resolve under the new structure."

Ziemer won't be replaced.

Dem Senators Grill HHS Secretary over Proposed Title X Changes

While the new FY 2019 budget maintains the same level of funding for Title X programs -- federal programs focused on family planning and related preventive services, including birth control -- Sen. Patty Murray (D-Ore.) criticized the administration for its plan to exclude Planned Parenthood from participating in the program.

Asked whether Azar would pledge to maintain a network of safety net providers who deliver "the full range of high-quality family planning services" to four million people nationwide, Azar said, "Whatever we would do with Title X will ensure appropriate access to Title X services as well as broader services."

"We have the lowest teen pregnancy rates ever ... I don't understand. Why are we fooling around with something that's been working ... to focus on an approach that all of the data that I've seen shows doesn't work?"she asked.

Azar again stated that the administration's approach is to provide access to a "broad range of providers" and philosophies and stressed that one would not be favored over another.

"They gave a loaded gun to a person who's suicidal," said Dustin McKee, of the doctors who prescribed opioids to his brother, Brandon Johnathan McKee.

In 2014, Brandon McKee was in a car accident, leaving him with several shattered vertebrae that required surgery. Because of a provision within 42CFR Part 2 -- the section of the Code of Federal Regulations that relates to confidentiality for substance use disorder patients' medical records -- the orthopedic surgeon who performed the surgery was unaware that the patient struggled with substance abuse, McKee said.

At the hearing before a subcommittee of the House Energy and Commerce Committee, Dustin McKee testified in support of a discussion draft of "The Overdose Prevention and Patient Safety Act," which would align Part 2 as it's commonly referred to with the Health Insurance Portability and Accountability Act (HIPAA).

"The manufacturers all claim that they're not benefiting from increases in price, and that their net price is approximately the same, yet we see this enormous tripling ... in the cost of insulin," said committee chairman Susan Collins (R-Maine). "So what's going on here? Who's making the money that's causing these enormous price increases, and are manufacturers correct when they say, 'We're not the ones; our net price is relatively stable over time'?"

In 2013, more was spent on insulin than on all other diabetes medications combined, Collins said in her opening remarks. "In a new report to be released today, the American Diabetes Association notes that between 2002 and 2013, the average price of insulin nearly tripled."

This occurred with a drug that is nearly 100 years old -- it was discovered in 1921 by three scientists at the University of Toronto, Collins noted. "The scientists sold the patent for one dollar each to the university ... They explicitly stated that profit was not their goal."

New Product to Stop GI Bleeds Approved

An endoscopically delivered spray to stop upper and lower gastrointestinal bleeding is now approved for marketing, the FDA said Monday.

Called Hemospray and to be sold by Cook Medical although technically Wilson-Cook, all marketing materials call the company Cook and this is the commonly used name, the product is an aerosolized mineral blend that can cover large areas, according to the FDA's announcement.

Data submitted to the agency, from clinical trials and "real-world" evidence in published journal reports, indicated that the product stopped bleeding in 95% of patients within 5 minutes. Recurrent bleeding was seen in 20%, mostly within the first 72 hours, the FDA said. Hemospray has been available in Canada and a number of other markets worldwide for several years.

Bowel perforation -- a risk with any lower GI endoscopic procedure -- was seen in 1%. The FDA noted that the product is not indicated for variceal bleeding, and is contraindicated in patients with GI fistulas or at high risk for GI perforations.

And the American Enterprise Institute, USC-Brookings Schaeffer Initiative for Health Policy, and the Pacific Business Group on Health will examine strategies for fixing healthcare through changes to purchasing.

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